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Clevidipine in the Postoperative Treatment of Hypertension

This study has been completed.
Sponsor:
Information provided by:
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00093925
First received: October 7, 2004
Last updated: October 29, 2008
Last verified: October 2008
History of Changes
  Purpose

The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension.


Condition Intervention Phase
Hypertension
 Drug: Clevidipine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Clevidipine in the Postoperative Treatment of Hypertension Assessing Safety Events (With Nicardipine as Active Comparator) (ECLIPSE-NIC)

Resource links provided by NLM:

Drug Information available for: Clevidipine
U.S. FDA Resources

Further study details as provided by The Medicines Company:

Estimated Enrollment: 500
Study Start Date: October 2004
Estimated Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Prerandomization Inclusion Criteria:

  • Provide written informed consent before initiation of any study related procedures.
  • Be at least 18 years of age
  • Be scheduled for Coronary Artery Bypass Grafting (CABG), Off Pump Coronary Artery Bypass (OPCAB), Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) surgery, and/or valve replacement/repair surgery

Prerandomization Exclusion Criteria:

  • Women of child-bearing potential (unless they have a negative pregnancy test)
  • Recent cerebrovascular accident (within 3 months before randomization)
  • Known intolerance to calcium channel blockers
  • Known or suspected hypersensitivity to nicardipine
  • Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
  • Pre-existing permanent ventricular pacing
  • Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial
  • Participation in another therapeutic drug or therapeutic device trial within 30 days of starting study

Postrandomization Inclusion Criteria:

  • Expected to survive beyond 24 hours post-surgical procedure
  • No surgical complications or conditions, present or anticipated, that preclude them from inclusion in the study
  • Determined to be hypertensive postoperatively as determined by the investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093925

Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
United States, Kansas
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
Touro Infirmary
New Orleans, Louisiana, United States, 70115
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Jack D. Weller Hospital
Bronx, New York, United States, 10461
Columbia University - College of Physicians and Surgeons
New York, New York, United States, 10032
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
VA Medical Center McGuire
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
The Medicines Company
Investigators
Study Director: Malcolm Lloyd, MD The Medicines Company - Medical Director, Clinical Operations
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00093925     History of Changes
Other Study ID Numbers: TMC-CLV-03-05, ECLIPSE-NIC
Study First Received: October 7, 2004
Last Updated: October 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
Postoperative hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013